Moderate to Severe Psoriasis
Conditions
Keywords
Etanercept, Acitretin, Psoriasis
Brief summary
To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.
Interventions
DRUGEtanercept
Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks
DRUGEtanercept + Acitretin
Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks
DRUGAcitretin
Acitretin at a dose of 10mg BID for 24 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10. * In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy. * Negative urine pregnancy test before the first dose of study drug in all female patients
Exclusion criteria
* Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. * Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes. * Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 | Week 24 | Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence). |
| Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint). |
| Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild). |
| Time to Achieve a PASI 50 Score | Baseline up to Week 24 | PASI 50 defined as a 50% or greater improvement in PASI score from Baseline |
| Time to Achieve a PASI 75 Score | Baseline up to Week 24 | PASI 75 defined as a 75% or greater improvement in PASI score from Baseline |
| Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Baseline up to Week 24 | PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild). |
| Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear | Baseline up to Week 24 | PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint). |
| Change From Baseline in the PGA of Psoriasis | Baseline, Weeks 2, 4, 8, 12, 18, and 24 | PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement. |
| Change From Baseline in the PASI Score | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90-100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section \* area score \* weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement. |
| Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement. |
| Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement. |
| Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Baseline, Weeks 2, 4, 8, 12 ,18 and 24 | Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement. |
| Change From Baseline in SGA of Itching at Each Visit | Baseline, Weeks 2, 4, 8, 12 ,18 and 24 | Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Weeks 2, 4, 8, 12, 18, and 24 | Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement I would like to continue with my current psoriasis treatment. Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement. |
| Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory? Percentage of participants who responded yes reported. |
| Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory? Percentage of participants who responded yes reported. |
| Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline, Weeks 2, 4, 8, 12, 18 and 24 | Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks | 21 |
| Etanercept and Acitretin Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks. | 19 |
| Acitretin Acitretin 10 mg subcutaneous injection BID for 24 weeks | 18 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 4 |
Baseline characteristics
| Characteristic | Etanercept | Etanercept and Acitretin | Acitretin | Total |
|---|---|---|---|---|
| Age Continuous | 38.57 years STANDARD_DEVIATION 9.53 | 35.5 years STANDARD_DEVIATION 8.75 | 42.39 years STANDARD_DEVIATION 11.95 | 38.78 years STANDARD_DEVIATION 10.31 |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 15 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 21 | 14 / 20 | 10 / 18 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 | 1 / 18 |
Outcome results
Primary
Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24
Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time frame: Week 24
Population: Modified intent to treat (mITT) population: randomized participants who took at least 1 dose of test article and had both baseline and on-therapy PASI evaluations; Last Observation Carried Forward (LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 | 52.38 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 | 57.89 percentage of participants |
| Acitretin | Percentage of Participants Achieving a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 | 22.22 percentage of participants |
Comparison: Overall treatment differencep-value: 0.0672Fisher Exact
Secondary
Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24
Change from Baseline in the percentage of the surface area of the body affected by psoriasis. Change = Week x minus Baseline, where smaller scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -2.64 percentage of BSA | Standard Deviation 6.69 |
| Etanercept | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | -15.43 percentage of BSA | Standard Deviation 14.9 |
| Etanercept | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | -12.67 percentage of BSA | Standard Deviation 13.17 |
| Etanercept | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 32.98 percentage of BSA | Standard Deviation 20.21 |
| Etanercept | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | -17.52 percentage of BSA | Standard Deviation 14.91 |
| Etanercept | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | -16.57 percentage of BSA | Standard Deviation 14.7 |
| Etanercept | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -7.36 percentage of BSA | Standard Deviation 10.89 |
| Etanercept and Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | -7.97 percentage of BSA | Standard Deviation 9.27 |
| Etanercept and Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 32.50 percentage of BSA | Standard Deviation 24.15 |
| Etanercept and Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -1.55 percentage of BSA | Standard Deviation 5.07 |
| Etanercept and Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -4.50 percentage of BSA | Standard Deviation 6.48 |
| Etanercept and Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | -10.29 percentage of BSA | Standard Deviation 9.19 |
| Etanercept and Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | -14.76 percentage of BSA | Standard Deviation 11.61 |
| Etanercept and Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | -16.87 percentage of BSA | Standard Deviation 10.79 |
| Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | -5.08 percentage of BSA | Standard Deviation 11.89 |
| Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.36 percentage of BSA | Standard Deviation 5.54 |
| Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | -10.30 percentage of BSA | Standard Deviation 18.86 |
| Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | -9.25 percentage of BSA | Standard Deviation 16.72 |
| Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | -5.14 percentage of BSA | Standard Deviation 16.96 |
| Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -0.75 percentage of BSA | Standard Deviation 7.66 |
| Acitretin | Change From Baseline in Percent Body Surface Area (BSA) Involvement of Psoriasis at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 39.75 percentage of BSA | Standard Deviation 22.96 |
Comparison: Overall treatment difference at Week 2p-value: 0.1385ANCOVA
Comparison: Overall treatment difference at Week 4p-value: 0.0019ANCOVA
Comparison: Overall treatment difference at Week 8p-value: 0.0442ANCOVA
Comparison: Overall treatment difference at Week 12p-value: 0.0034ANCOVA
Comparison: Overall treatment difference at Week 18p-value: 0.0454ANCOVA
Comparison: Overall treatment difference at Week 24p-value: 0.0539ANCOVA
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their anxiety. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 1.05 Units on a scale | Standard Deviation 1.66 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.52 Units on a scale | Standard Deviation 2.14 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.57 Units on a scale | Standard Deviation 1.91 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.29 Units on a scale | Standard Deviation 1.87 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.24 Units on a scale | Standard Deviation 1.95 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.57 Units on a scale | Standard Deviation 2.01 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.24 Units on a scale | Standard Deviation 1.55 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.47 Units on a scale | Standard Deviation 1.95 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.89 Units on a scale | Standard Deviation 1.73 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.63 Units on a scale | Standard Deviation 1.89 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.21 Units on a scale | Standard Deviation 1.84 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.68 Units on a scale | Standard Deviation 1.73 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.53 Units on a scale | Standard Deviation 1.87 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.58 Units on a scale | Standard Deviation 1.68 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.22 Units on a scale | Standard Deviation 2.6 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.39 Units on a scale | Standard Deviation 1.54 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.67 Units on a scale | Standard Deviation 2.25 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.56 Units on a scale | Standard Deviation 2.15 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.33 Units on a scale | Standard Deviation 2.06 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -0.61 Units on a scale | Standard Deviation 1.61 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 10, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.22 Units on a scale | Standard Deviation 1.8 |
Comparison: Overall treatment difference at Week 2p-value: 0.0512Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.0024Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.0946Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.0935Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.2073Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.3415Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their depression. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.95 Units on a scale | Standard Deviation 1.32 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.71 Units on a scale | Standard Deviation 2.05 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.38 Units on a scale | Standard Deviation 1.83 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.43 Units on a scale | Standard Deviation 1.91 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.19 Units on a scale | Standard Deviation 2.02 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.57 Units on a scale | Standard Deviation 2.09 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.33 Units on a scale | Standard Deviation 1.59 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.47 Units on a scale | Standard Deviation 2.2 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.95 Units on a scale | Standard Deviation 1.72 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 1.11 Units on a scale | Standard Deviation 1.63 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.26 Units on a scale | Standard Deviation 1.97 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.58 Units on a scale | Standard Deviation 1.64 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.47 Units on a scale | Standard Deviation 1.81 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.68 Units on a scale | Standard Deviation 1.7 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.17 Units on a scale | Standard Deviation 2.04 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.11 Units on a scale | Standard Deviation 1.18 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.67 Units on a scale | Standard Deviation 1.5 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.61 Units on a scale | Standard Deviation 1.58 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.28 Units on a scale | Standard Deviation 1.41 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -0.22 Units on a scale | Standard Deviation 1.59 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 11, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.33 Units on a scale | Standard Deviation 1.85 |
Comparison: Overall treatment difference at Week 2p-value: 0.0202Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.009Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.0742Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.0445Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.2211Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.1982Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their fatigue. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.48 Units on a scale | Standard Deviation 1.86 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.48 Units on a scale | Standard Deviation 1.89 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.29 Units on a scale | Standard Deviation 1.82 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.95 Units on a scale | Standard Deviation 1.75 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.24 Units on a scale | Standard Deviation 2.02 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.48 Units on a scale | Standard Deviation 1.89 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.29 Units on a scale | Standard Deviation 1.76 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.95 Units on a scale | Standard Deviation 2.07 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.74 Units on a scale | Standard Deviation 1.52 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.89 Units on a scale | Standard Deviation 1.56 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.68 Units on a scale | Standard Deviation 1.8 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.95 Units on a scale | Standard Deviation 1.72 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.37 Units on a scale | Standard Deviation 1.61 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.21 Units on a scale | Standard Deviation 2.2 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | -0.89 Units on a scale | Standard Deviation 2.42 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.72 Units on a scale | Standard Deviation 1.99 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | -0.67 Units on a scale | Standard Deviation 2.06 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | -0.61 Units on a scale | Standard Deviation 2.06 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | -0.33 Units on a scale | Standard Deviation 2.35 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -0.56 Units on a scale | Standard Deviation 2.01 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 12, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.78 Units on a scale | Standard Deviation 1.73 |
Comparison: Overall treatment difference at Week 2p-value: 0.0409Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.145Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.201Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.0424Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.009Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.0116Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how others responded to their personal appearance at work/school. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.29 Units on a scale | Standard Deviation 1.85 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.00 Units on a scale | Standard Deviation 1.73 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.05 Units on a scale | Standard Deviation 1.69 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.95 Units on a scale | Standard Deviation 1.99 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.95 Units on a scale | Standard Deviation 1.86 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.95 Units on a scale | Standard Deviation 1.91 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.00 Units on a scale | Standard Deviation 1.67 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.74 Units on a scale | Standard Deviation 1.05 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.63 Units on a scale | Standard Deviation 1.46 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.53 Units on a scale | Standard Deviation 1.02 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.53 Units on a scale | Standard Deviation 1.5 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.11 Units on a scale | Standard Deviation 1.56 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.53 Units on a scale | Standard Deviation 1.43 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.42 Units on a scale | Standard Deviation 1.57 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | -0.22 Units on a scale | Standard Deviation 1.77 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.83 Units on a scale | Standard Deviation 1.62 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.11 Units on a scale | Standard Deviation 2.14 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | -0.33 Units on a scale | Standard Deviation 1.88 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -0.33 Units on a scale | Standard Deviation 1.91 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.39 Units on a scale | Standard Deviation 1.58 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 13, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | -0.11 Units on a scale | Standard Deviation 2.05 |
Comparison: Overall treatment difference at Week 2p-value: 0.3355Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.0341Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.0899Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.0062Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.1241Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.0393Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on how their skin affected social and leisure activities. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.57 Units on a scale | Standard Deviation 2.09 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.57 Units on a scale | Standard Deviation 1.36 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.10 Units on a scale | Standard Deviation 1.64 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.76 Units on a scale | Standard Deviation 1.79 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 2.10 Units on a scale | Standard Deviation 2.02 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.95 Units on a scale | Standard Deviation 1.02 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.90 Units on a scale | Standard Deviation 1.84 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.89 Units on a scale | Standard Deviation 0.94 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.68 Units on a scale | Standard Deviation 1.7 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.95 Units on a scale | Standard Deviation 1.61 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.89 Units on a scale | Standard Deviation 0.99 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.58 Units on a scale | Standard Deviation 1.61 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.74 Units on a scale | Standard Deviation 1.41 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.89 Units on a scale | Standard Deviation 1.52 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.50 Units on a scale | Standard Deviation 1.82 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.39 Units on a scale | Standard Deviation 1.5 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.06 Units on a scale | Standard Deviation 1.43 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.22 Units on a scale | Standard Deviation 1.73 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.28 Units on a scale | Standard Deviation 1.45 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | -0.06 Units on a scale | Standard Deviation 1.7 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 14, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.28 Units on a scale | Standard Deviation 2.08 |
Comparison: Overall treatment difference at Week 2p-value: 0.3402Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.1184Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.0104Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.001Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.025Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.041Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 5-point scale: very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 1.24 Units on a scale | Standard Deviation 1.18 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.90 Units on a scale | Standard Deviation 1.51 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.67 Units on a scale | Standard Deviation 1.32 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.19 Units on a scale | Standard Deviation 1.12 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.38 Units on a scale | Standard Deviation 1.47 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.86 Units on a scale | Standard Deviation 1.56 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.67 Units on a scale | Standard Deviation 1.2 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.37 Units on a scale | Standard Deviation 1.83 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.37 Units on a scale | Standard Deviation 1.21 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 1.00 Units on a scale | Standard Deviation 1.6 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.00 Units on a scale | Standard Deviation 1.37 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.53 Units on a scale | Standard Deviation 1.74 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.74 Units on a scale | Standard Deviation 1.52 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.68 Units on a scale | Standard Deviation 1.6 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.35 Units on a scale | Standard Deviation 1.87 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.18 Units on a scale | Standard Deviation 1.55 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.76 Units on a scale | Standard Deviation 1.95 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.82 Units on a scale | Standard Deviation 1.78 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.53 Units on a scale | Standard Deviation 1.55 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.12 Units on a scale | Standard Deviation 1.58 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 15, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.41 Units on a scale | Standard Deviation 1.18 |
Comparison: Overall treatment difference at Week 2p-value: 0.0894Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.0084Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.0727Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.0337Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.138Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.3415Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to respond to the statement I would like to continue with my current psoriasis treatment. Responses were based on a 5-point scale: strongly disagree (0), disagree(1), neither agree nor disagree (2), agree (3), strongly agree (4). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.48 Units on a scale | Standard Deviation 1.17 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.48 Units on a scale | Standard Deviation 1.5 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.52 Units on a scale | Standard Deviation 1.54 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 3.10 Units on a scale | Standard Deviation 1.22 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.14 Units on a scale | Standard Deviation 1.53 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.48 Units on a scale | Standard Deviation 1.5 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.67 Units on a scale | Standard Deviation 1.24 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.26 Units on a scale | Standard Deviation 1.05 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 3.42 Units on a scale | Standard Deviation 1.02 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.11 Units on a scale | Standard Deviation 1.2 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.05 Units on a scale | Standard Deviation 1.18 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.11 Units on a scale | Standard Deviation 1.1 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.16 Units on a scale | Standard Deviation 1.21 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.21 Units on a scale | Standard Deviation 1.13 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.82 Units on a scale | Standard Deviation 1.42 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | -0.29 Units on a scale | Standard Deviation 2.14 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.00 Units on a scale | Standard Deviation 1.8 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | -0.18 Units on a scale | Standard Deviation 1.88 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.06 Units on a scale | Standard Deviation 1.98 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -0.12 Units on a scale | Standard Deviation 1.93 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 16, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | -0.29 Units on a scale | Standard Deviation 2.08 |
Comparison: Overall treatment difference at Week 2p-value: 0.4407Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.1768Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.4636Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.334Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.1785Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.7428Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the overall appearance of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 2.10 Units on a scale | Standard Deviation 1.58 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.81 Units on a scale | Standard Deviation 1.25 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.67 Units on a scale | Standard Deviation 0.8 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 2.10 Units on a scale | Standard Deviation 1.58 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.76 Units on a scale | Standard Deviation 1.67 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.57 Units on a scale | Standard Deviation 1.16 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 2.24 Units on a scale | Standard Deviation 1.87 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.74 Units on a scale | Standard Deviation 0.99 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.58 Units on a scale | Standard Deviation 1.71 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.74 Units on a scale | Standard Deviation 1.76 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.95 Units on a scale | Standard Deviation 1.54 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.79 Units on a scale | Standard Deviation 1.4 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.95 Units on a scale | Standard Deviation 1.31 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 2.05 Units on a scale | Standard Deviation 1.18 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.28 Units on a scale | Standard Deviation 1.41 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.56 Units on a scale | Standard Deviation 1.38 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.11 Units on a scale | Standard Deviation 1.84 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.50 Units on a scale | Standard Deviation 1.38 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.44 Units on a scale | Standard Deviation 0.78 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.06 Units on a scale | Standard Deviation 1.66 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 1, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.78 Units on a scale | Standard Deviation 1.4 |
Comparison: Overall treatment difference at Week 2p-value: 0.3112Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.0196Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.0109Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.0035Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.0603Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.2184Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the flaking of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.00 Units on a scale | Standard Deviation 1.3 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 2.33 Units on a scale | Standard Deviation 2.01 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 2.67 Units on a scale | Standard Deviation 1.88 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.57 Units on a scale | Standard Deviation 1.36 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 1.14 Units on a scale | Standard Deviation 1.53 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.90 Units on a scale | Standard Deviation 2.17 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 2.38 Units on a scale | Standard Deviation 1.83 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 1.21 Units on a scale | Standard Deviation 1.51 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.68 Units on a scale | Standard Deviation 1.42 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.53 Units on a scale | Standard Deviation 1.95 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.63 Units on a scale | Standard Deviation 1.46 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.89 Units on a scale | Standard Deviation 1.41 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 2.21 Units on a scale | Standard Deviation 1.18 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.84 Units on a scale | Standard Deviation 1.21 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.28 Units on a scale | Standard Deviation 1.84 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.94 Units on a scale | Standard Deviation 1.66 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.56 Units on a scale | Standard Deviation 0.78 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.17 Units on a scale | Standard Deviation 1.86 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.83 Units on a scale | Standard Deviation 1.76 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.11 Units on a scale | Standard Deviation 1.78 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 2, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.39 Units on a scale | Standard Deviation 1.5 |
Comparison: Overall treatment difference at Week 2p-value: 0.1774Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.1195Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.0606Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.003Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.1567Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.2094Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on the redness of their skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 2.05 Units on a scale | Standard Deviation 2.04 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.86 Units on a scale | Standard Deviation 1.2 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 2.05 Units on a scale | Standard Deviation 2.2 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.95 Units on a scale | Standard Deviation 1.24 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 2.19 Units on a scale | Standard Deviation 1.97 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.90 Units on a scale | Standard Deviation 1.18 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 2.00 Units on a scale | Standard Deviation 2.02 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 2.16 Units on a scale | Standard Deviation 1.21 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 2.21 Units on a scale | Standard Deviation 1.23 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.63 Units on a scale | Standard Deviation 1.01 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 1.32 Units on a scale | Standard Deviation 1.34 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.16 Units on a scale | Standard Deviation 1.17 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.58 Units on a scale | Standard Deviation 1.71 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.68 Units on a scale | Standard Deviation 1.67 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.72 Units on a scale | Standard Deviation 0.89 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.61 Units on a scale | Standard Deviation 1.38 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.83 Units on a scale | Standard Deviation 1.34 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.00 Units on a scale | Standard Deviation 1.41 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.17 Units on a scale | Standard Deviation 1.2 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.22 Units on a scale | Standard Deviation 1.52 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 3, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.44 Units on a scale | Standard Deviation 1.04 |
Comparison: Overall treatment difference at Week 2p-value: 0.0302Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.098Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.0711Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.0077Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.1553Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.041Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on tightness in the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.33 Units on a scale | Standard Deviation 1.28 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 2.67 Units on a scale | Standard Deviation 2.18 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 2.48 Units on a scale | Standard Deviation 2.16 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 1.48 Units on a scale | Standard Deviation 1.5 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 2.19 Units on a scale | Standard Deviation 1.72 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 2.43 Units on a scale | Standard Deviation 2.34 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.90 Units on a scale | Standard Deviation 2.47 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 2.05 Units on a scale | Standard Deviation 1.18 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.11 Units on a scale | Standard Deviation 1.05 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 2.00 Units on a scale | Standard Deviation 1.05 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.42 Units on a scale | Standard Deviation 1.61 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.32 Units on a scale | Standard Deviation 1.29 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.74 Units on a scale | Standard Deviation 1.48 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.79 Units on a scale | Standard Deviation 1.13 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.61 Units on a scale | Standard Deviation 2.2 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.78 Units on a scale | Standard Deviation 1.77 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.56 Units on a scale | Standard Deviation 1.62 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.44 Units on a scale | Standard Deviation 1.79 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.11 Units on a scale | Standard Deviation 1.57 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.83 Units on a scale | Standard Deviation 1.76 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 4, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.83 Units on a scale | Standard Deviation 1.76 |
Comparison: Overall treatment difference at Week 2p-value: 0.006Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.0058Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.0127Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.0068Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.0096Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.0132Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on bleeding of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.57 Units on a scale | Standard Deviation 1.6 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.43 Units on a scale | Standard Deviation 2.23 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.43 Units on a scale | Standard Deviation 1.99 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.38 Units on a scale | Standard Deviation 2.25 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.00 Units on a scale | Standard Deviation 1.95 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.00 Units on a scale | Standard Deviation 2.32 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.81 Units on a scale | Standard Deviation 1.86 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.84 Units on a scale | Standard Deviation 1.64 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.68 Units on a scale | Standard Deviation 1.53 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.74 Units on a scale | Standard Deviation 1.45 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.05 Units on a scale | Standard Deviation 1.22 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.74 Units on a scale | Standard Deviation 1.28 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.16 Units on a scale | Standard Deviation 1.92 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.84 Units on a scale | Standard Deviation 1.64 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.78 Units on a scale | Standard Deviation 2.41 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.28 Units on a scale | Standard Deviation 1.74 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.61 Units on a scale | Standard Deviation 2.2 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.67 Units on a scale | Standard Deviation 2.09 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.44 Units on a scale | Standard Deviation 1.82 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.56 Units on a scale | Standard Deviation 2.09 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 5, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.89 Units on a scale | Standard Deviation 2.14 |
Comparison: Overall treatment difference at Week 2p-value: 0.6904Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.7021Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.2199Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.5071Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.4765Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.8662Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on burning sensation of the skin. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.67 Units on a scale | Standard Deviation 2.35 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.14 Units on a scale | Standard Deviation 1.96 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.86 Units on a scale | Standard Deviation 1.98 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.57 Units on a scale | Standard Deviation 1.57 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.81 Units on a scale | Standard Deviation 1.69 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.24 Units on a scale | Standard Deviation 1.92 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.76 Units on a scale | Standard Deviation 1.81 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.37 Units on a scale | Standard Deviation 1.86 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.37 Units on a scale | Standard Deviation 1.3 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.89 Units on a scale | Standard Deviation 1.49 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.37 Units on a scale | Standard Deviation 1.54 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.16 Units on a scale | Standard Deviation 1.86 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.58 Units on a scale | Standard Deviation 1.71 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.05 Units on a scale | Standard Deviation 1.72 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.56 Units on a scale | Standard Deviation 2.28 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.44 Units on a scale | Standard Deviation 1.65 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.44 Units on a scale | Standard Deviation 2.06 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.61 Units on a scale | Standard Deviation 2.33 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.78 Units on a scale | Standard Deviation 1.9 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -0.06 Units on a scale | Standard Deviation 2.53 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 6, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.28 Units on a scale | Standard Deviation 2.05 |
Comparison: Overall treatment difference at Week 2p-value: 0.1144Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.4509Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.435Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.6085Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.2582Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.549Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on skin pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.29 Units on a scale | Standard Deviation 2.05 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.48 Units on a scale | Standard Deviation 1.75 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.62 Units on a scale | Standard Deviation 2.27 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.10 Units on a scale | Standard Deviation 2.02 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.95 Units on a scale | Standard Deviation 1.63 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.90 Units on a scale | Standard Deviation 1.76 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.24 Units on a scale | Standard Deviation 2 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.63 Units on a scale | Standard Deviation 1.71 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.32 Units on a scale | Standard Deviation 1.45 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.32 Units on a scale | Standard Deviation 1.45 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.89 Units on a scale | Standard Deviation 1.59 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.00 Units on a scale | Standard Deviation 1.41 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.37 Units on a scale | Standard Deviation 1.89 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.21 Units on a scale | Standard Deviation 1.78 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.67 Units on a scale | Standard Deviation 2.14 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 2.72 Units on a scale | Standard Deviation 2.11 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.28 Units on a scale | Standard Deviation 1.96 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.50 Units on a scale | Standard Deviation 2.26 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.89 Units on a scale | Standard Deviation 2.3 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.78 Units on a scale | Standard Deviation 2.73 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 7, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.00 Units on a scale | Standard Deviation 2.45 |
Comparison: Overall treatment difference at Week 2p-value: 0.3287Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.4149Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.3837Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.6777Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.4976Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.4189Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on joint pain. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | -0.29 Units on a scale | Standard Deviation 1.15 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -0.52 Units on a scale | Standard Deviation 1.21 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | -0.57 Units on a scale | Standard Deviation 1.47 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | -0.33 Units on a scale | Standard Deviation 1.2 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | -0.14 Units on a scale | Standard Deviation 0.85 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.33 Units on a scale | Standard Deviation 1.11 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 4.43 Units on a scale | Standard Deviation 1.16 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.05 Units on a scale | Standard Deviation 1.22 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 3.79 Units on a scale | Standard Deviation 1.4 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.05 Units on a scale | Standard Deviation 1.18 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.05 Units on a scale | Standard Deviation 0.91 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.21 Units on a scale | Standard Deviation 1.03 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.21 Units on a scale | Standard Deviation 1.18 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.37 Units on a scale | Standard Deviation 1.38 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.17 Units on a scale | Standard Deviation 0.99 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | -0.28 Units on a scale | Standard Deviation 1.6 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.00 Units on a scale | Standard Deviation 2.35 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 4.17 Units on a scale | Standard Deviation 1.58 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.22 Units on a scale | Standard Deviation 1.77 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.17 Units on a scale | Standard Deviation 1.95 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 8, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.33 Units on a scale | Standard Deviation 1.53 |
Comparison: Overall treatment difference at Week 2p-value: 0.476Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.404Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.4753Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.5084Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.2293Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.3822Kruskal-Wallis
Secondary
Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to rate, based on their experience during the past week, how satisfied or dissatisfied they were with the treatment's effect on their comfort level with their personal appearance. Responses were based on a 5-point scale: Very dissatisfied (0), Dissatisfied (1), Neither satisfied nor dissatisfied (2), Satisfied (3), Very satisfied (4), Never had this problem (5). Change = Week X minus Baseline, where larger scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.43 Units on a scale | Standard Deviation 1.21 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.52 Units on a scale | Standard Deviation 2.18 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.48 Units on a scale | Standard Deviation 1.91 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 1.14 Units on a scale | Standard Deviation 1.56 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 1.57 Units on a scale | Standard Deviation 2.29 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.90 Units on a scale | Standard Deviation 2.51 |
| Etanercept | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 0.90 Units on a scale | Standard Deviation 1.64 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 1.58 Units on a scale | Standard Deviation 1.61 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.79 Units on a scale | Standard Deviation 0.79 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | 0.63 Units on a scale | Standard Deviation 1.46 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | 1.05 Units on a scale | Standard Deviation 1.43 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 1.89 Units on a scale | Standard Deviation 1.41 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 1.68 Units on a scale | Standard Deviation 1.29 |
| Etanercept and Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 2.21 Units on a scale | Standard Deviation 1.13 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 12 | 0.17 Units on a scale | Standard Deviation 1.34 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 2 | -0.11 Units on a scale | Standard Deviation 1.23 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 24 | 0.78 Units on a scale | Standard Deviation 1.44 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 18 | 0.72 Units on a scale | Standard Deviation 1.45 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 8 | 0.44 Units on a scale | Standard Deviation 1.29 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Change at Week 4 | -0.11 Units on a scale | Standard Deviation 1.23 |
| Acitretin | Change From Baseline in Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 9, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 0.83 Units on a scale | Standard Deviation 1.1 |
Comparison: Overall treatment difference at Week 2p-value: 0.2691Kruskal-Wallis
Comparison: Overall treatment difference at Week 4p-value: 0.0142Kruskal-Wallis
Comparison: Overall treatment difference at Week 8p-value: 0.0383Kruskal-Wallis
Comparison: Overall treatment difference at Week 12p-value: 0.0026Kruskal-Wallis
Comparison: Overall treatment difference at Week 18p-value: 0.0475Kruskal-Wallis
Comparison: Overall treatment difference at Week 24p-value: 0.0205Kruskal-Wallis
Secondary
Change From Baseline in SGA of Itching at Each Visit
Participants were asked to rate the severity of their psoriasis itching on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12 ,18 and 24
Population: mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in SGA of Itching at Each Visit | Change at Week 24 | -1.19 units on a scale | Standard Deviation 2.23 |
| Etanercept | Change From Baseline in SGA of Itching at Each Visit | Baseline | 3.33 units on a scale | Standard Deviation 1.35 |
| Etanercept | Change From Baseline in SGA of Itching at Each Visit | Change at Week 2 | -0.67 units on a scale | Standard Deviation 1.59 |
| Etanercept | Change From Baseline in SGA of Itching at Each Visit | Change at Week 4 | -1.52 units on a scale | Standard Deviation 1.33 |
| Etanercept | Change From Baseline in SGA of Itching at Each Visit | Change at Week 8 | -1.86 units on a scale | Standard Deviation 2.06 |
| Etanercept | Change From Baseline in SGA of Itching at Each Visit | Change at Week 12 | -2.10 units on a scale | Standard Deviation 2.07 |
| Etanercept | Change From Baseline in SGA of Itching at Each Visit | Change at Week 18 | -1.81 units on a scale | Standard Deviation 2.06 |
| Etanercept and Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 18 | -1.83 units on a scale | Standard Deviation 1.76 |
| Etanercept and Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 4 | -0.61 units on a scale | Standard Deviation 1.65 |
| Etanercept and Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 8 | -1.06 units on a scale | Standard Deviation 1.76 |
| Etanercept and Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 24 | -1.83 units on a scale | Standard Deviation 2.04 |
| Etanercept and Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 12 | -1.44 units on a scale | Standard Deviation 2.09 |
| Etanercept and Acitretin | Change From Baseline in SGA of Itching at Each Visit | Baseline | 3.11 units on a scale | Standard Deviation 1.81 |
| Etanercept and Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 2 | 0.28 units on a scale | Standard Deviation 1.74 |
| Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 24 | -1.06 units on a scale | Standard Deviation 1.89 |
| Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 12 | -1.22 units on a scale | Standard Deviation 1.73 |
| Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 4 | -0.39 units on a scale | Standard Deviation 2.03 |
| Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 18 | -1.17 units on a scale | Standard Deviation 1.62 |
| Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 2 | -0.39 units on a scale | Standard Deviation 1.29 |
| Acitretin | Change From Baseline in SGA of Itching at Each Visit | Change at Week 8 | -1.28 units on a scale | Standard Deviation 1.71 |
| Acitretin | Change From Baseline in SGA of Itching at Each Visit | Baseline | 3.72 units on a scale | Standard Deviation 1.45 |
Comparison: Overall treatment difference at Week 2p-value: 0.1229ANCOVA
Comparison: Overall treatment difference at Week 4p-value: 0.0136ANCOVA
Comparison: Overall treatment difference at Week 8p-value: 0.1578ANCOVA
Comparison: Overall treatment difference at Week 12p-value: 0.0565ANCOVA
Comparison: Overall treatment difference at Week 18p-value: 0.0685ANCOVA
Comparison: Overall treatment difference at Week 24p-value: 0.0493ANCOVA
Secondary
Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24
Participants were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12 ,18 and 24
Population: mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 2 | -0.90 units on a scale | Standard Deviation 1.58 |
| Etanercept | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 12 | -2.67 units on a scale | Standard Deviation 1.56 |
| Etanercept | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 8 | -2.29 units on a scale | Standard Deviation 1.79 |
| Etanercept | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Baseline | 3.90 units on a scale | Standard Deviation 1.09 |
| Etanercept | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 24 | -1.81 units on a scale | Standard Deviation 2.2 |
| Etanercept | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 18 | -2.57 units on a scale | Standard Deviation 1.99 |
| Etanercept | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 4 | -1.86 units on a scale | Standard Deviation 1.28 |
| Etanercept and Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 8 | -1.89 units on a scale | Standard Deviation 1.49 |
| Etanercept and Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Baseline | 3.94 units on a scale | Standard Deviation 1.06 |
| Etanercept and Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 2 | -0.33 units on a scale | Standard Deviation 1.24 |
| Etanercept and Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 4 | -0.94 units on a scale | Standard Deviation 1.26 |
| Etanercept and Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 12 | -2.28 units on a scale | Standard Deviation 1.53 |
| Etanercept and Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 18 | -2.11 units on a scale | Standard Deviation 1.78 |
| Etanercept and Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 24 | -2.39 units on a scale | Standard Deviation 1.54 |
| Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 12 | -1.61 units on a scale | Standard Deviation 1.72 |
| Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 2 | -0.72 units on a scale | Standard Deviation 1.02 |
| Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 24 | -1.72 units on a scale | Standard Deviation 1.93 |
| Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 18 | -1.83 units on a scale | Standard Deviation 1.76 |
| Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 8 | -1.67 units on a scale | Standard Deviation 1.71 |
| Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 4 | -0.83 units on a scale | Standard Deviation 1.04 |
| Acitretin | Change From Baseline in SGA of Psoriasis at Weeks 2, 4, 8, 12 ,18 and 24 | Baseline | 4.72 units on a scale | Standard Deviation 0.67 |
Comparison: Overall treatment difference at Week 2p-value: 0.1079ANCOVA
Comparison: Overall treatment difference at Week 4p-value: 0.0004ANCOVA
Comparison: Overall treatment difference at Week 8p-value: 0.0146ANCOVA
Comparison: Overall treatment difference at Week 12p-value: 0.0019ANCOVA
Comparison: Overall treatment difference at Week 18p-value: 0.0062ANCOVA
Comparison: Overall treatment difference at Week 24p-value: 0.0197ANCOVA
Secondary
Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24
Participants were asked to rate the severity of their joint pain on a 6-point scale, where 0=good and 5=severe. Change = Week X minus Baseline, where smaller scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF; Number of participants analyzed (N)= participants with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 2 | 0.00 units on a scale | Standard Deviation 0.71 |
| Etanercept | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 12 | 0.00 units on a scale | Standard Deviation 0.63 |
| Etanercept | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 8 | 0.19 units on a scale | Standard Deviation 0.81 |
| Etanercept | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Baseline | 0.67 units on a scale | Standard Deviation 1.43 |
| Etanercept | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 24 | 0.29 units on a scale | Standard Deviation 1.06 |
| Etanercept | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 18 | -0.05 units on a scale | Standard Deviation 0.67 |
| Etanercept | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 4 | 0.29 units on a scale | Standard Deviation 1.19 |
| Etanercept and Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 8 | -0.22 units on a scale | Standard Deviation 0.88 |
| Etanercept and Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Baseline | 0.56 units on a scale | Standard Deviation 1.15 |
| Etanercept and Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 2 | 0.00 units on a scale | Standard Deviation 0.49 |
| Etanercept and Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 4 | -0.06 units on a scale | Standard Deviation 0.42 |
| Etanercept and Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 12 | -0.28 units on a scale | Standard Deviation 0.96 |
| Etanercept and Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 18 | -0.28 units on a scale | Standard Deviation 1.02 |
| Etanercept and Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 24 | -0.39 units on a scale | Standard Deviation 0.85 |
| Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 12 | -0.44 units on a scale | Standard Deviation 2.36 |
| Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 2 | -0.44 units on a scale | Standard Deviation 1.1 |
| Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 24 | -0.61 units on a scale | Standard Deviation 2.03 |
| Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 18 | -0.44 units on a scale | Standard Deviation 1.85 |
| Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 8 | -0.56 units on a scale | Standard Deviation 1.72 |
| Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Change at Week 4 | -0.72 units on a scale | Standard Deviation 1.81 |
| Acitretin | Change From Baseline in Subject Global Assessment (SGA) of Joint Pain at Weeks 2, 4, 8, 12 ,18 and 24 | Baseline | 0.94 units on a scale | Standard Deviation 1.73 |
Comparison: Overall treatment difference at Week 2p-value: 0.1723ANCOVA
Comparison: Overall treatment difference at Week 4p-value: 0.0292ANCOVA
Comparison: Overall treatment difference at Week 8p-value: 0.0908ANCOVA
Comparison: Overall treatment difference at Week 12p-value: 0.5678ANCOVA
Comparison: Overall treatment difference at Week 18p-value: 0.482ANCOVA
Comparison: Overall treatment difference at Week 24p-value: 0.0394ANCOVA
Secondary
Change From Baseline in the PASI Score
Combined assessment of lesion severity, area affected into single score; range:0(no disease) to 72(maximal disease).Body divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated:0(0%) to 6(90-100%), severity estimated by clinical signs: erythema, induration, desquamation; scale: 0(none) to 4(maximum). Final PASI = sum of severity parameters for each section \* area score \* weight of section(head:0.1,arm:0.2,body: 0.3, leg:0.4). Change=Week X-Baseline, smaller scores show improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in the PASI Score | Change at Week 18 | -12.13 units on a scale | Standard Deviation 11.67 |
| Etanercept | Change From Baseline in the PASI Score | Change at Week 12 | -11.97 units on a scale | Standard Deviation 11.63 |
| Etanercept | Change From Baseline in the PASI Score | Change at Week 4 | -9.98 units on a scale | Standard Deviation 10.64 |
| Etanercept | Change From Baseline in the PASI Score | Change at Week 8 | -11.11 units on a scale | Standard Deviation 10.89 |
| Etanercept | Change From Baseline in the PASI Score | Change at Week 24 | -12.16 units on a scale | Standard Deviation 12.15 |
| Etanercept | Change From Baseline in the PASI Score | Change at Week 2 | -5.38 units on a scale | Standard Deviation 7.13 |
| Etanercept | Change From Baseline in the PASI Score | Baseline | 20.83 units on a scale | Standard Deviation 14.02 |
| Etanercept and Acitretin | Change From Baseline in the PASI Score | Change at Week 24 | -13.92 units on a scale | Standard Deviation 5.75 |
| Etanercept and Acitretin | Change From Baseline in the PASI Score | Baseline | 19.75 units on a scale | Standard Deviation 9.85 |
| Etanercept and Acitretin | Change From Baseline in the PASI Score | Change at Week 2 | -3.27 units on a scale | Standard Deviation 1.88 |
| Etanercept and Acitretin | Change From Baseline in the PASI Score | Change at Week 4 | -6.45 units on a scale | Standard Deviation 3.19 |
| Etanercept and Acitretin | Change From Baseline in the PASI Score | Change at Week 8 | -9.96 units on a scale | Standard Deviation 3.73 |
| Etanercept and Acitretin | Change From Baseline in the PASI Score | Change at Week 12 | -11.39 units on a scale | Standard Deviation 4.72 |
| Etanercept and Acitretin | Change From Baseline in the PASI Score | Change at Week 18 | -13.54 units on a scale | Standard Deviation 6.8 |
| Acitretin | Change From Baseline in the PASI Score | Change at Week 2 | -3.17 units on a scale | Standard Deviation 5.6 |
| Acitretin | Change From Baseline in the PASI Score | Baseline | 26.31 units on a scale | Standard Deviation 13.63 |
| Acitretin | Change From Baseline in the PASI Score | Change at Week 12 | -6.71 units on a scale | Standard Deviation 6.81 |
| Acitretin | Change From Baseline in the PASI Score | Change at Week 24 | -9.62 units on a scale | Standard Deviation 10.1 |
| Acitretin | Change From Baseline in the PASI Score | Change at Week 4 | -4.06 units on a scale | Standard Deviation 5.68 |
| Acitretin | Change From Baseline in the PASI Score | Change at Week 18 | -8.77 units on a scale | Standard Deviation 8.54 |
| Acitretin | Change From Baseline in the PASI Score | Change at Week 8 | -6.84 units on a scale | Standard Deviation 9.57 |
Comparison: Overall treatment difference at Week 2p-value: 0.0329ANCOVA
Comparison: Overall treatment difference at Week 4p-value: 0.0003ANCOVA
Comparison: Overall treatment difference at Week 8p-value: 0.0598ANCOVA
Comparison: Overall treatment difference at Week 12p-value: 0.0241ANCOVA
Comparison: Overall treatment difference at Week 18p-value: 0.0543ANCOVA
Comparison: Overall treatment difference at Week 24p-value: 0.1205ANCOVA
Secondary
Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin, medicine side effects and medicine ease/difficulty of use, do you consider that your current psoriasis treatment is satisfactory? Percentage of participants who responded yes reported.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 24 | 80.95 percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 8 | 90.48 percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 38.10 percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 2 | 80.95 percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 4 | 85.71 percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 12 | 95.24 percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 18 | 90.48 percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 18 | 94.74 percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 4 | 94.74 percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 8 | 89.47 percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 12 | 73.68 percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 24 | 94.74 percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 2 | 78.95 percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 42.11 percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 12 | 61.11 percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 33.33 percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 8 | 66.67 percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 18 | 61.11 percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 2 | 50.00 percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 4 | 55.56 percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 18, at Weeks 2, 4, 8, 12, 18 and 24 | Week 24 | 55.56 percentage of participants |
Comparison: Overall treatment difference at Baselinep-value: 0.9429Fisher Exact
Comparison: Overall treatment difference at Week 2p-value: 0.0927Fisher Exact
Comparison: Overall treatment difference at Week 4p-value: 0.0151Fisher Exact
Comparison: Overall treatment difference at Week 8p-value: 0.1124Fisher Exact
Comparison: Overall treatment difference at Week 12p-value: 0.0242Fisher Exact
Comparison: Overall treatment difference at Week 18p-value: 0.0237Fisher Exact
Comparison: Overall treatment difference at Week 24p-value: 0.0176Fisher Exact
Secondary
Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24
Participants completed a satisfaction survey at baseline and throughout the study. Participants were asked to answer the following question with either a yes or no, Taking into account your psoriasis symptoms, the appearance of your skin and all other problems which psoriasis causes, do you consider that your current health state is satisfactory? Percentage of participants who responded yes reported.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 12 | 71.43 Percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 4 | 42.86 Percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 24 | 57.14 Percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 8 | 57.14 Percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 18 | 71.43 Percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 2 | 14.29 Percentage of participants |
| Etanercept | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 9.52 Percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 24 | 73.68 Percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 15.79 Percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 2 | 42.11 Percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 4 | 52.63 Percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 8 | 57.89 Percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 12 | 57.89 Percentage of participants |
| Etanercept and Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 18 | 63.16 Percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 2 | 27.78 Percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 18 | 38.89 Percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 12 | 33.33 Percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Baseline | 22.22 Percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 4 | 33.33 Percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 24 | 38.89 Percentage of participants |
| Acitretin | Change From Baseline in the Percentage of Participants Who Responded Yes to the Psoriasis Subject Satisfaction Questionnaire (PSSQ) Question 17, at Weeks 2, 4, 8, 12, 18 and 24 | Week 8 | 33.33 Percentage of participants |
Comparison: Overall treatment difference at Baselinep-value: 0.5377Fisher Exact
Comparison: Overall treatment difference at Week 2p-value: 0.1419Fisher Exact
Comparison: Overall treatment difference at Week 4p-value: 0.5391Fisher Exact
Comparison: Overall treatment difference at Week 8p-value: 0.2589Fisher Exact
Comparison: Overall treatment difference at Week 12p-value: 0.0635Fisher Exact
Comparison: Overall treatment difference at Week 18p-value: 0.1172Fisher Exact
Comparison: Overall treatment difference at Week 24p-value: 0.1247Fisher Exact
Secondary
Change From Baseline in the PGA of Psoriasis
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence). Change = Week x, minus Baseline, where smaller scores indicate improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12, 18, and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in the PGA of Psoriasis | Change at Week 4 | -1.00 units on a scale | Standard Deviation 1.03 |
| Etanercept | Change From Baseline in the PGA of Psoriasis | Baseline | 3.40 units on a scale | Standard Deviation 0.82 |
| Etanercept | Change From Baseline in the PGA of Psoriasis | Change at Week 2 | -0.51 units on a scale | Standard Deviation 0.71 |
| Etanercept | Change From Baseline in the PGA of Psoriasis | Change at Week 8 | -1.34 units on a scale | Standard Deviation 1.07 |
| Etanercept | Change From Baseline in the PGA of Psoriasis | Change at Week 12 | -1.62 units on a scale | Standard Deviation 1.33 |
| Etanercept | Change From Baseline in the PGA of Psoriasis | Change at Week 18 | -1.58 units on a scale | Standard Deviation 1.33 |
| Etanercept | Change From Baseline in the PGA of Psoriasis | Change at Week 24 | -1.67 units on a scale | Standard Deviation 1.47 |
| Etanercept and Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 2 | -0.35 units on a scale | Standard Deviation 0.58 |
| Etanercept and Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 8 | -1.09 units on a scale | Standard Deviation 0.86 |
| Etanercept and Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 4 | -0.84 units on a scale | Standard Deviation 0.6 |
| Etanercept and Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 12 | -1.42 units on a scale | Standard Deviation 0.69 |
| Etanercept and Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 24 | -1.86 units on a scale | Standard Deviation 1.06 |
| Etanercept and Acitretin | Change From Baseline in the PGA of Psoriasis | Baseline | 3.38 units on a scale | Standard Deviation 0.59 |
| Etanercept and Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 18 | -1.68 units on a scale | Standard Deviation 1 |
| Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 12 | -0.48 units on a scale | Standard Deviation 0.98 |
| Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 2 | 0.02 units on a scale | Standard Deviation 0.56 |
| Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 4 | -0.26 units on a scale | Standard Deviation 0.74 |
| Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 18 | -0.69 units on a scale | Standard Deviation 1.35 |
| Acitretin | Change From Baseline in the PGA of Psoriasis | Baseline | 3.50 units on a scale | Standard Deviation 0.92 |
| Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 8 | -0.43 units on a scale | Standard Deviation 0.91 |
| Acitretin | Change From Baseline in the PGA of Psoriasis | Change at Week 24 | -0.71 units on a scale | Standard Deviation 1.37 |
Comparison: Overall treatment difference at Week 2p-value: 0.0203ANCOVA
Comparison: Overall treatment difference at Week 4p-value: 0.0102ANCOVA
Comparison: Overall treatment difference at Week 8p-value: 0.0056ANCOVA
Comparison: Overall treatment difference at Week 12p-value: 0.0006ANCOVA
Comparison: Overall treatment difference at Week 18p-value: 0.0066ANCOVA
Comparison: Overall treatment difference at Week 24p-value: 0.0058ANCOVA
Secondary
Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score
Combined assessment of lesion severity and area affected into single score; range: 0 (no disease) to 72 (maximal disease). Body was divided into 4 sections (head, arms, trunk, legs); each area scored by itself and scores combined for final PASI. For each section, area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (exceptionally striking). Final PASI = sum of severity parameters for each section \* area score \* weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time frame: Weeks 2, 4, 8, 12, 18, and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 8 | 71.43 percentage of participants |
| Etanercept | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 24 | 71.43 percentage of participants |
| Etanercept | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 18 | 76.19 percentage of participants |
| Etanercept | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 2 | 4.76 percentage of participants |
| Etanercept | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 12 | 76.19 percentage of participants |
| Etanercept | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 4 | 47.62 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 18 | 84.21 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 8 | 57.89 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 12 | 78.95 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 24 | 84.21 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 2 | 0 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 4 | 15.79 percentage of participants |
| Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 2 | 0 percentage of participants |
| Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 4 | 11.11 percentage of participants |
| Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 18 | 38.89 percentage of participants |
| Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 12 | 22.22 percentage of participants |
| Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 24 | 44.44 percentage of participants |
| Acitretin | Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score | Week 8 | 27.78 percentage of participants |
Comparison: Overall treatment difference Week 2p-value: 1Fisher Exact
Comparison: Overall treatment difference Week 4p-value: 0.0229Fisher Exact
Comparison: Overall treatment difference Week 8p-value: 0.0256Fisher Exact
Comparison: Overall treatment difference Week 12p-value: 0.0004Fisher Exact
Comparison: Overall treatment difference Week 18p-value: 0.0105Fisher Exact
Comparison: Overall treatment difference Week 24p-value: 0.0366Fisher Exact
Secondary
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 24 | 52.38 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Baseline | 0 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 2 | 0 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 4 | 19.05 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 8 | 28.57 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 12 | 42.86 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 18 | 33.33 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 8 | 21.05 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Baseline | 0 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 4 | 5.26 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 12 | 21.05 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 2 | 0 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 24 | 52.63 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 18 | 31.58 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 24 | 16.67 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 18 | 16.67 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 4 | 11.11 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Baseline | 0 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 2 | 5.56 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 12 | 5.56 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear | Week 8 | 5.56 percentage of participants |
Comparison: Overall treatment difference at Week 2p-value: 0.3103Fisher Exact
Comparison: Overall treatment difference at Week 4p-value: 0.4763Fisher Exact
Comparison: Overall treatment difference at Week 8p-value: 0.1961Fisher Exact
Comparison: Overall treatment difference at Week 12p-value: 0.0272Fisher Exact
Comparison: Overall treatment difference at Week 18p-value: 0.5038Fisher Exact
Comparison: Overall treatment difference at Week 24p-value: 0.0374Fisher Exact
Secondary
Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), 2 (mild).
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 2 | 33.33 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 12 | 76.19 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 8 | 61.90 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Baseline | 14.29 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 24 | 76.19 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 18 | 80.95 percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 4 | 42.86 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 8 | 42.11 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Baseline | 5.26 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 2 | 26.32 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 4 | 47.37 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 12 | 78.95 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 18 | 84.21 percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 24 | 84.21 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 12 | 33.33 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 2 | 11.11 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 24 | 33.33 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 18 | 38.89 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 8 | 27.78 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Week 4 | 16.67 percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | Baseline | 16.67 percentage of participants |
Comparison: Overall treatment difference at Baselinep-value: 0.6061Fisher Exact
Comparison: Overall treatment difference at Week 2p-value: 0.2971Fisher Exact
Comparison: Overall treatment difference at Week 4p-value: 0.1119Fisher Exact
Comparison: Overall treatment difference at Week 8p-value: 0.1081Fisher Exact
Comparison: Overall treatment difference at Week 12p-value: 0.0063Fisher Exact
Comparison: Overall treatment difference at Week 18p-value: 0.0055Fisher Exact
Comparison: Overall treatment difference at Week 24p-value: 0.0031Fisher Exact
Secondary
Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear = PGA score of 0 (no evidence).
Time frame: Baseline, Weeks 2, 4, 8, 12, 18 and 24
Population: mITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 12 | 9.52 Percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 18 | 9.52 Percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 24 | 9.52 Percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 4 | 0 Percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 2 | 0 Percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Baseline | 0 Percentage of participants |
| Etanercept | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 8 | 4.76 Percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Baseline | 0 Percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 8 | 0 Percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 18 | 5.26 Percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 4 | 0 Percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 12 | 0 Percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 24 | 10.53 Percentage of participants |
| Etanercept and Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 2 | 0 Percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 18 | 5.56 Percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 4 | 0 Percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 8 | 0 Percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 24 | 5.56 Percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 2 | 0 Percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Week 12 | 0 Percentage of participants |
| Acitretin | Percentage of Participants Achieving a Status on the Physician Global Assessment (PGA) of Psoriasis of Clear | Baseline | 0 Percentage of participants |
Comparison: Overall treatment difference at Week 8p-value: 1Fisher Exact
Comparison: Overall treatment difference at Week 12p-value: 0.323Fisher Exact
Comparison: Overall treatment difference at Week 18p-value: 1Fisher Exact
Comparison: Overall treatment difference at Week 24p-value: 1Fisher Exact
Secondary
Time to Achieve a PASI 50 Score
PASI 50 defined as a 50% or greater improvement in PASI score from Baseline
Time frame: Baseline up to Week 24
Population: mITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etanercept | Time to Achieve a PASI 50 Score | 56 days |
| Etanercept and Acitretin | Time to Achieve a PASI 50 Score | 56 days |
| Acitretin | Time to Achieve a PASI 50 Score | 126 days |
Comparison: Overall treatment differencep-value: 0.0033Log Rank
Secondary
Time to Achieve a PASI 75 Score
PASI 75 defined as a 75% or greater improvement in PASI score from Baseline
Time frame: Baseline up to Week 24
Population: mITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etanercept | Time to Achieve a PASI 75 Score | 126 days |
| Etanercept and Acitretin | Time to Achieve a PASI 75 Score | 146 days |
| Acitretin | Time to Achieve a PASI 75 Score | NA days |
Comparison: Overall treatment differencep-value: 0.0448Log Rank
Secondary
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear = PGA score of 0 (no evidence), or 1 (minimal/faint).
Time frame: Baseline up to Week 24
Population: mITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etanercept | Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear | 167 days |
| Etanercept and Acitretin | Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear | 165 days |
| Acitretin | Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear | NA days |
Comparison: Overall treatment differencep-value: 0.3536Log Rank
Secondary
Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild
PGA of Psoriasis: score based on dermatologist's assessment of disease averaged over all lesions of head, scalp, and neck. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease. Assessment of clear or almost clear or mild = PGA score of 0 (no evidence), 1 (minimal/faint), or 2 (mild).
Time frame: Baseline up to Week 24
Population: mITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etanercept | Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | 57 days |
| Etanercept and Acitretin | Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | 57 days |
| Acitretin | Time to Achieve a Status on the PGA of Psoriasis of Clear or Almost Clear or Mild | 169 days |
Comparison: Overall treatment differencep-value: 0.0041Log Rank